General MedicationsSUBCUTANEOUSStandard

XYOSTED (AUTOINJECTOR)

TESTOSTERONE ENANTHATE

Standard Dose

100MG/0.5ML (100MG/0.5ML)

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Prescription

Summary

Approval overview XYOSTED (AUTOINJECTOR) is listed in Drugs@FDA under application 209863 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE ENANTHATE Form and strength SOLUTION;SUBCUTANEOUS - 100MG/0.5ML (100MG/0.5ML) Sponsor ANTARES PHARMA INC Submission history Latest submission status date: 2025-07-11 00:00:00.

Structured Monograph

Clinical summary

Approval overview XYOSTED (AUTOINJECTOR) is listed in Drugs@FDA under application 209863 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TESTOSTERONE ENANTHATE Form and strength SOLUTION;SUBCUTANEOUS - 100MG/0.5ML (100MG/0.5ML) Sponsor ANTARES PHARMA INC Submission history Latest submission status date: 2025-07-11 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Prescription
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.